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Sk90 replied to the topic The change from ALARP to AFAP in the forum Risk Analysis for Medical Devices 6 years, 5 months ago
ALAPRP is ‘as low as reasonably practicable’. It requires weighing the risk against the time,cost needed to control it. Deciding whether the risk is ALARP is quite challenging because it requires the duty holder to exercise judgement. In a complex situation build on good practice are used to make formal decision that includes cost -benefit analysis. Everyone in the organization should know about it because it is a fundamental to the work of whole organization. AFAP is reducing risk as far as possible. As the complexity of risk increases the reduction becomes more complicated. It means little risk reduction requires before risk at hand becomes negligible.